AuthorisedPhase III and phase IV (Integrated)Interventional

Ultrasound-guided Radiofrequency Ablation versus radioactive Iodine as treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules (RABITO study)

This study, called RABITO, is looking at two ways to treat an overactive thyroid lump (solitary autonomous thyroid nodule). One treatment is a new method called ultrasound-guided radiofrequency ablation, which uses heat to shrink the lump. The other is a standard treatment, radioactive iodine, given as capsules. The main goal is to see which treatment leads to fewer patients developing an underactive thyroid (hypothyroidism) in the first year. Researchers will also check how effectively each treatment cures the overactive thyroid, measure the size of the lump, look at side effects, and understand how the treatments affect patients' quality of life and healthcare costs in the UK. This study is for adults aged 18 and over.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Rijnstate Ziekenhuis Stichting

Enrolment target

232

Start

17 Jan 2025

Hyperactive thyroid nodules

What is this study about?

This study, known as the RABITO study, is designed to help doctors understand the best way to treat a specific type of overactive thyroid problem. Sometimes, a single lump, called a nodule, in your thyroid gland can become overactive and produce too many thyroid hormones. This can make you feel unwell.

The study is comparing two different treatments. One is a standard treatment called radioactive iodine, where you take a capsule containing a small amount of radiation. This radiation helps to calm down the overactive cells in the nodule. The other treatment is newer and involves using ultrasound (sound waves) to guide a special probe. This probe then uses heat to shrink the overactive lump. This is called radiofrequency ablation.

Doctors want to find out which treatment is better at curing the overactive nodule without causing a common side effect: developing an underactive thyroid. They will also look at how these treatments affect your general well-being, your quality of life, and what the costs are to the healthcare system. The results will help doctors make better decisions about treatment for patients like you in the future.

Key takeaways

Compares two treatments for an overactive thyroid lump: radioactive iodine and heat treatment.
Mainly looking at which causes fewer patients to get an underactive thyroid after treatment.
Also checking how well treatments work, side effects, and quality of life.
For adults aged 18 and over with a specific type of overactive thyroid lump.
Participation involves appointments for tests, scans, and questionnaires.
You can stop participating at any time.

Who may be eligible?

This study is particularly for adults aged 18 years and older who have a single overactive lump in their thyroid gland. It's important that this lump is the cause of your thyroid being overactive, not another condition.

Both men and women can take part in this study. The medical team will carefully check your health and medical history to make sure that taking part is safe and suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a single overactive lump in your thyroid gland?
Has your doctor confirmed this lump is causing your thyroid to be overactive?
Are you able to attend appointments for follow-up tests and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either radioactive iodine or the ultrasound-guided heat treatment. You would have appointments for blood tests and scans, including ultrasounds of your thyroid, before treatment, and then at specific times over the following year, and potentially up to five years. These appointments help the doctors check how your thyroid is working, measure the size of the lump, and monitor for any side effects. You might also be asked to fill out questionnaires about how you're feeling and your quality of life at various points. The total duration of active follow-up for the main goals of the study is one year, with some extended monitoring for up to five years.

Potential risks and benefits

Participating in this study might mean you receive a new treatment that could be more effective or have fewer side effects than current options. Both treatments being studied are known medical procedures, but like all medical interventions, they carry potential risks. For example, radioactive iodine can sometimes lead to an underactive thyroid. The heat treatment might have its own specific risks, which the study team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is an 'overactive thyroid nodule'?

It's a single lump in your thyroid gland that produces too much thyroid hormone, making your body's processes speed up.

What is radioactive iodine?

It's a common treatment where you take a capsule with a small amount of radiation that helps calm down the overactive thyroid cells.

What is radiofrequency ablation?

It's a newer treatment that uses heat, guided by ultrasound, to shrink and reduce the activity of the overactive thyroid lump.

What does a 'Phase III and IV' study mean?

Phase III means it's comparing a new treatment to a standard one, and Phase IV means collecting more information on an approved treatment after it's been widely used, often combined here to get a full picture.

Will I know which treatment I'm getting?

You'll be assigned to one of the treatments, and the study team will explain everything to you before you start. In some studies, you might not know, but they will clarify this.